NCT07612839

Brief Summary

This prospective randomized controlled study aims to evaluate the effect of perioperative intravenous lidocaine infusion on postoperative fatigue syndrome in patients undergoing elective laparoscopic TAPP inguinal hernia repair. Participants will be randomly assigned to receive either intravenous lidocaine infusion or standard perioperative management without lidocaine. The primary objective is to assess postoperative fatigue and recovery quality. Secondary outcomes include postoperative pain, analgesic consumption, nausea-vomiting, mobilization time, and length of hospital stay.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Jun 2026Sep 2026

First Submitted

Initial submission to the registry

May 21, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 29, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

June 5, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2026

Last Updated

May 29, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

May 21, 2026

Last Update Submit

May 21, 2026

Conditions

Keywords

Intravenous LidocainePostoperative FatigueLaparoscopic TAPP RepairPostoperative Recovery

Outcome Measures

Primary Outcomes (1)

  • Postoperative Fatigue Syndrome Score

    Assessment of postoperative fatigue syndrome and recovery quality using postoperative follow-up evaluations conducted on postoperative days 1, 3 and 5 after elective laparoscopic TAPP inguinal hernia repair.

    Postoperative days 1, 3, 5

Secondary Outcomes (3)

  • Postoperative Pain Score

    Postoperative days 1, 3, and 5

  • Opioid Consumption

    Within postoperative 24 hours

  • Postoperative Nausea and Vomiting

    Within postoperative 24 hours

Study Arms (2)

Lidocaine Group

EXPERIMENTAL

Participants in this group will receive perioperative intravenous lidocaine infusion according to ideal body weight. A loading dose of 1.5 mg/kg lidocaine diluted in 50 or 100 mL normal saline will be administered over 10 minutes before surgery, followed by an infusion of 1.5 mg/kg/hour during surgery. If the operation exceeds 2 hours, the infusion will be discontinued. The duration of surgery will be recorded. Lidocaine infusion will be stopped immediately if signs suggestive of local anesthetic systemic toxicity or unexplained hemodynamic instability occur during surgery.

Drug: Lidocaine

Control Group

NO INTERVENTION

Participants in this group will receive standard perioperative care without intravenous lidocaine infusion during elective laparoscopic TAPP inguinal hernia repair.

Interventions

Perioperative intravenous lidocaine infusion will be administered according to the study protocol in patients undergoing elective laparoscopic TAPP inguinal hernia repair.

Lidocaine Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients aged 18 years and older Patients scheduled for elective laparoscopic TAPP inguinal hernia repair under general anesthesia ASA physical status I-II Patients who provide written informed consent -

You may not qualify if:

  • Moderate to severe hepatic dysfunction Low cardiac output or severe heart failure Severe cardiac conduction abnormalities or clinically significant arrhythmias Planned concomitant use of high-dose local anesthetics, including infiltration or regional block Advanced age or frailty Pregnancy or breastfeeding Known allergy or contraindication to lidocaine Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences Sultan Abdulhamid Han Training and Research Hospital

Istanbul, Istanbul, 34668, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Hakan Emirkadı, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to either the intravenous lidocaine group or the control group in a parallel-group design.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Anesthesiology and Reanimation Specialist

Study Record Dates

First Submitted

May 21, 2026

First Posted

May 29, 2026

Study Start

June 5, 2026

Primary Completion (Estimated)

August 10, 2026

Study Completion (Estimated)

September 10, 2026

Last Updated

May 29, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

No individual participant data will be shared because the study involves sensitive clinical data and no public data-sharing plan has been established.

Locations